在临床试验和药物批准中的天然产品衍生化合物
Mark S Butler1, Robert J Capon2, Mark A T Blaskovich1,3
1Centre for Superbug Solutions, Australia. m.butler2@imb.uq.edu.au.
Natural product reports
|September 9, 2025
概括
自然产品 (NP) 在药物发现中仍然至关重要,自2014年以来,已批准了56种NP衍生药物. 重新关注生物测试引导的隔离对于识别这些有价值化合物的新药引擎至关重要.
科学领域:
- 制药科学 制药科学
- 药用化学 医学化学
- 药物发现 药物发现 药物发现
背景情况:
- 自然产品 (NPs) 历史上一直是医学和药物发现的基石.
- 技术的进步导致NP在药物开发中的作用减少,但仍然很重要.
- 本综述探讨了NP对药物批准和临床开发的当代影响.
研究的目的:
- 分析2014年1月至2025年6月期间批准的自然产品衍生药物 (NP-D) 的数量和类型.
- 评估NP和NP-D化合物在2024年12月临床开发中的情况.
- 突出天然产品在制药创新的持续意义和未来潜力.
主要方法:
- 从2014年到2024年,在全球范围内对药物批准进行系统审查.
- 对新化学实体 (NCE) 和新生物实体 (NBE) 的分析,包括NP-抗体药物合物 (NP-ADC).
- 在临床试验和注册阶段识别和分类NP和NP-D化合物.
主要成果:
- 2014年1月至2025年6月期间,已推出58种NP相关药物,其中包括45种NP和NP-DNCE和13种NP-ADC.
- 在2014-2024年全球批准的579种药物中,56种 (9.7%) 被归类为NP或NP-Ds.
- 125种NP和NP-D化合物正在临床开发中,发现了33种新型药,尽管最近只发现了一种.
结论:
- 自然产品仍然是批准药物和临床候选药物的重要来源.
- 尽管年度批准率波动,但NP-D药物占新批准的显著比例.
- 建议进一步强调生物试验引导的隔离和作用模式研究,以释放天然产品的全部潜力,以便在未来发现药物.
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